Esophageal Cancer Clinical Trial

Evaluation of MicroRNA Expression in Blood and Cytology for Detecting Barrett’s Esophagus and Associated Neoplasia

Summary

The primary purpose of this study is to test new methods to diagnose BE in time before it turns into advanced cancer. Once BE is diagnosed, the current standard of care is to monitor the disease so that complication such as cancer can be diagnosed early. The two new methods the investigators are evaluating are: a) blood test and b) brush test of the food pipe. The investigators will collect blood, bile and cells from the food pipe and stomach and measure for a biomarker called microRNA (miRNA). In the future, measurements of microRNA biomarkers could help the doctors figure out which patients are at increased risk for cancer of the esophagus.

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Full Description

The investigators will collect serum, bile and esophageal cells (using cytology devices) from consenting subjects. The investigators have previously identified BE specific miRNA that will be tested on the cytology specimens. These are miRNAs -192-5p, -215-5p and -194-5p. The investigators have also identified serum microRNAs in whole serum and exosomes by sequencing to study further. The investigators will also evaluate miRNA expression within biliary exosomes for the first time in patients with reflux related diseases.

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Eligibility Criteria

Inclusion Criteria:

Patient age: > 18 years
Ability to provide written, informed consent

Exclusion Criteria:

Pregnancy or planning a pregnancy
History of nasal, esophageal & gastric surgery
History of recurrent epistaxis or nasal trauma
Subjects with a history of unresolved drug or alcohol dependency
Inability to obtain biopsies due to a coagulopathy, varices, thrombocytopenia, etc.
Subjects with inadequate cytology specimens will not undergo repeat test and will be excluded from the study
Inability to provide written informed consent
Inability to discontinue drugs such as Plavix
Advanced chronic liver disease
Severe uncontrolled coagulopathy
Active cancer in any organ over the past 3 years.

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

220

Study ID:

NCT02464930

Recruitment Status:

Unknown status

Sponsor:

Midwest Biomedical Research Foundation

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There is 1 Location for this study

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Kansas City Veterans Affairs Medical Center
Kansas City Missouri, 64128, United States More Info
AJAY BANSAL, MD
Contact
816-861-4700
[email protected]
Andrew Price, AS
Contact
816-861-4700
[email protected]
Ajay Bansal
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

220

Study ID:

NCT02464930

Recruitment Status:

Unknown status

Sponsor:


Midwest Biomedical Research Foundation

How clear is this clinincal trial information?

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